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V930 First in Man (FIM) Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00250419
First received: November 7, 2005
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  Purpose

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.


Condition Intervention Phase
Cancers Expressing HER-2 and/or CEA
 Biological: V930
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Merck:

Enrollment: 26
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: V930
    Other Name: V930
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
  • Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy
  • Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion Criteria:

  • Patients with prior treatment with any HER-2 and/or CEA containing vaccine
  • Patients who have significant cardiac disease
  • Patients with autoimmune disorders
  • Patients who are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250419

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00250419     History of Changes
Other Study ID Numbers: 2005_047, V930-002
Study First Received: November 7, 2005
Last Updated: May 19, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 13, 2013